21 quantitative lc-msms analysis of 15 estrogens and estrogen metabolites in human plasma using...

11
Primera Analytical Solutions Corp. Primera Analytical Solutions Corp.

Upload: cpsa-20125-minutes-fame

Post on 13-Jun-2015

208 views

Category:

Technology


0 download

DESCRIPTION

5 minutes of fame

TRANSCRIPT

Page 1: 21 quantitative lc-msms analysis of 15 estrogens and estrogen metabolites in human plasma using supported liquid extraction (sle) technique steve cines - primera analytical solutions

Primera Analytical Solutions Corp.Primera Analytical Solutions Corp.

Page 2: 21 quantitative lc-msms analysis of 15 estrogens and estrogen metabolites in human plasma using supported liquid extraction (sle) technique steve cines - primera analytical solutions

Founded in 2002.

Strong, solid, steady organic growth.

Strong base of PhD level scientists heading our groups.

Working relationships with many international and domestic pharmaceutical enterprises

Primera Analytical Solutions Corp.Primera Analytical Solutions Corp.

Page 3: 21 quantitative lc-msms analysis of 15 estrogens and estrogen metabolites in human plasma using supported liquid extraction (sle) technique steve cines - primera analytical solutions

GMP Analytical

Release Testing

Bioanalysis of Clinical Samples

Formulation Development

GMP Analytical Method Development, Validation

Stability Testing/Stability Indicating Method Development.

Method Transfer

Primera Analytical Solutions Corp.Primera Analytical Solutions Corp.

Page 4: 21 quantitative lc-msms analysis of 15 estrogens and estrogen metabolites in human plasma using supported liquid extraction (sle) technique steve cines - primera analytical solutions

UPLC/HPLC Experience SEC/GPC Ion Exchange Chiral Methods Conventional Reverse Phase Conventional Normal Phase

SDS PAGE

GC/FID, GC/MS, GC Headspace

HPLC Detection Systems CAD ELSD DAD RI FLD

Primera Analytical Solutions Corp.Primera Analytical Solutions Corp.

25.7

05

30.0

10

34.6

83

AU

0.000

0.010

0.020

0.030

0.040

0.050

0.060

0.070

0.080

0.090

0.100

0.110

0.120

Minutes

0.00 10.00 20.00 30.00 40.00 50.00 60.00 70.00

Page 5: 21 quantitative lc-msms analysis of 15 estrogens and estrogen metabolites in human plasma using supported liquid extraction (sle) technique steve cines - primera analytical solutions

Primera Analytical Solutions CorpPrimera Analytical Solutions Corp

Mass Spectroscopy Laboratory

Bioanalysis of Clinical Trial/BE

Samples

Method Transfer

Method Development

Method Validation

Clinical Partners

Page 6: 21 quantitative lc-msms analysis of 15 estrogens and estrogen metabolites in human plasma using supported liquid extraction (sle) technique steve cines - primera analytical solutions

Primera Analytical Solutions Corp.Primera Analytical Solutions Corp.

Characterization of Proteins and Peptides

SDS PAGE ELISA Protein Stability Studies Peptide Mapping with HPLC or LC/MS/MS Amino Acid Analysis Chiral Edman Degradation qPCR Cell Viability Assays. Endotoxins…

25.7

05

30.0

10

34.6

83

AU

-0.0005

0.0000

0.0005

0.0010

0.0015

0.0020

0.0025

0.0030

0.0035

0.0040

0.0045

Minutes

10.00 20.00 30.00 40.00 50.00 60.00 70.00

Page 7: 21 quantitative lc-msms analysis of 15 estrogens and estrogen metabolites in human plasma using supported liquid extraction (sle) technique steve cines - primera analytical solutions

Primera Analytical Solutions Corp.Primera Analytical Solutions Corp.

Preformulation

Physicochemical Properties

Particle size analysis

Solubility profile

pH and pKa determination

Solid and solution state stability

Drug-excipient compatibility

Drug-drug compatibility (combination drugs)

Page 8: 21 quantitative lc-msms analysis of 15 estrogens and estrogen metabolites in human plasma using supported liquid extraction (sle) technique steve cines - primera analytical solutions

Our Facilities Include: ICH Stability Chambers

Photostability Chamber

Full Power Back Up

-70C, -20C Freezers.

24/7 Alarms: Cellphone/Online Veriteq System

Unique Conditions Capability Primera Analytical Solutions Corp.Primera Analytical Solutions Corp.

Page 9: 21 quantitative lc-msms analysis of 15 estrogens and estrogen metabolites in human plasma using supported liquid extraction (sle) technique steve cines - primera analytical solutions

Robust System of SOP’s

Full GLP/GMP Staff Training Program

Secure Data Backup

FDA Audited 2008 and 2012

No 483’s

Primera Analytical Solutions Corp.Primera Analytical Solutions Corp.

Page 10: 21 quantitative lc-msms analysis of 15 estrogens and estrogen metabolites in human plasma using supported liquid extraction (sle) technique steve cines - primera analytical solutions

Primera Analytical Solutions Corp.Primera Analytical Solutions Corp.

Page 11: 21 quantitative lc-msms analysis of 15 estrogens and estrogen metabolites in human plasma using supported liquid extraction (sle) technique steve cines - primera analytical solutions

Thank You!!!Thank You!!!

Primera Analytical Solutions Corp.Primera Analytical Solutions Corp.

259 Wall Street259 Wall StreetPrinceton, NJ 08540Princeton, NJ 08540

(609) 921-7715(609) 921-7715

www.primera-corp.comwww.primera-corp.com